Hosting FDA Inspections - SOP for the preparation of regulatory inspections

SOP Hosting health agencies inspections

The purpose of this SOP Template is to describe the procedure for hosting inspections by regulatory agencies such as The Food and Drug Administration. Scope This procedure applies to all inspections conducted at a pharmaceutical or a medical device site by regulatory agencies to assess compliance with federal regulations and/or industry standards.

 

An inspection can be comprehensive, focused on a specific issue or set of issues, or in response to a reported problem. More than one Inspector/Investigator may be involved in the inspection. Investigation techniques may include observing operations, examining equipment, reviewing documents, collecting product samples, and interviewing employees. Inspector/Investigators will be treated with cooperation and courtesy during their visit. Inspector/Investigators will be permitted in the company facilities only during normal business hours and must be escorted at all times by the Inspection Coordinator or designee.

 

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